An international investigation to evaluate if, and if so how long, autologous bone marrow hematopoietic stem cell transplantation can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.
An international investigation to evaluate if, and if so how long, autologous bone marrow (ABM) hematopoietic stem cell transplantation (HSCT) can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Harvest and apheresis of bone marrow cells from HIV infected patients with cirrhosis under general anesthesia, using bone marrow collection system and transplanting the patients' hematopoietic stem cells back to the patients
National Center for Global Health and Medicine
Shinjuku, Tokyo, Japan
Post-transplantation prognosis for cirrhosis
Evaluate statistical significance between pre-transplantation and 24 weeks after in: * Child-Pugh score * albumin * serum fibrosis markers * Transient Elastography (TM) * ascites imagery * SF-36v2(TM) Health Survey. Because advanced liver cirrhosis is a progressive condition itself, treatment efficacy is defined by "improvement" and "no change" in the indicators listed.
Time frame: 24 weeks
Duration of the treatment efficacy
Using the same evaluation modules as of the primary outcomes, investigate and assess the autologous bone marrow transplantation effectivity chronologically after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy.
Time frame: After 24 weeks up to 48 weeks
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